05.12.25 -- CDMO Red Flags, Raw Material Strategy, And CGT Synergies

Gene therapy is complex—and so is writing about it. From viral vectors to cell types, every element demands deep understanding. Safety reporting adds further complexity: is an adverse event from chemotherapy, a procedure, or the gene therapy itself? These challenges require a thoughtful, flexible approach to document strategy and execution. Explore common hurdles and practical solutions for gene therapy document writing and submissions.

Understanding these synergies and their impact on efficiency, safety, and cost-effectiveness is essential for stakeholders navigating the complexities of cell and gene therapy development and production.

The development and manufacturability of antibody-oligonucleotide conjugates hinges on understanding and overcoming intricate chemistry and technical challenges.

Due to the complexity of biologics, precise analytical technology is crucial throughout every phase of drug development to ensure the highest standards of quality, safety, and regulatory compliance.

A Takeda production site in Linz, Austria, received an ISPE’s 2024 Facility of The Year Award. What’s so special about that location? The explanation from Roland Fabris, Site Head, will actually help you benchmark your CDMO, and demonstrate much about facility selection applicable to your own outsourcing needs. 

Review advice to pharma companies on three key areas of auto-injector device development: patient-centered design, container and device considerations, and manufacturing partner selection.

Emerging biotechs are behind many of the pharma industry’s latest therapeutic innovations. And while CDMOs are eager to work with them, they must learn to accommodate their unique needs.

The biopharmaceutical industry faces growing downstream processing challenges in purifying complex biologics efficiently and at scale.

As processes evolve, and as new challenges are highlighted by growth in newer modalities, the impact of filter choices will only grow. Having access to expertise can accelerate the journey to the right solution.

In this presentation, experts provide insight into transposase-mediated genome engineering, genetic quality control, and the maintenance of genetic stability in cell line generation.

Learn about an integrated drug substance/drug product offering for your IND program and beyond, with a holistic approach to ensure process robustness at every stage.

Discover how CDMOs can help you achieve and maintain CMC compliance throughout the drug development lifecycle. Outsourced Pharma Live will explore how to leverage CDMO expertise in process optimization, documentation, and regulatory submissions. Learn practical strategies to align your CMC goals with CDMO capabilities to accelerate development and ensure successful drug launches. Registration is free thanks to the support of Curia.

Eurofins delivers global GMP testing with 45+ facilities, ensuring regulatory acceptance, quality, and trusted service from starting materials to finished products.

From early development to commercialization, SGS provides comprehensive support in meeting regulatory expectations for characterization, potency, stability, and safety testing.

CEO and Founder of INCOG BioPharma Services, Cory Lewis, explains how the company is proud to be able to manufacture for the future of medicine.

Scaling your drug product from concept to commercial supply requires having the expertise to ask the right questions about your end goals, from the start.

Partner with a global network of cGMP-certified mammalian cell culture manufacturing facilities to ensure scalable, high-quality biologics production and seamless global supply.